Job Description
Role Overview
The Pharmacovigilance & Drug Safety Specialist is responsible for processing, reviewing, and reconciling adverse event and product complaint data within the patient management system. This role ensures clinical accuracy, regulatory alignment, and seamless communication with healthcare providers and biopharma clients.
Key Responsibilities
Adverse Event Reporting: Generate and submit precise adverse event (AE) and product complaint (PC) reports using patient management system documentation.
Quality Control (QC): Perform rigorous QC checks on notes to verify drug details, manufacturer names, spelling, grammar, and completeness.
Clinical Collaboration: Communicate directly with clinicians regarding documentation quality, missing data, or clarify questions on reported events.
Compliance & Tracking: Identify missing AE/PC reports through daily QC monitoring, ensuring all gaps are resolved and fully accounted for.
Client Reconciliation: Prepare and deliver weekly and monthly reconciliation reports to biopharma clients according to contractual agreements.
Audit Support: Assist the clinical auditor in identifying trends, systemic issues, and opportunities for workflow improvement.
Required Qualifications
Fast and accurate typing ability for both text and numerical data.
Moderate-to-advanced computer literacy, including intermediate/advanced proficiency in Microsoft Excel.
Excellent written and verbal communication skills.
High conscientiousness with exceptional attention to detail, organization, and time management.
Strong interpersonal skills with a team-first, adaptable, and flexible mindset.
Preferred Qualifications
Pharmacovigilance Experience: Direct prior experience with pharmacovigilance strongly preferred.
Clinical/Pharmacy Background: Prior experience in a pharmacy setting or as a Pharmacy Technician preferred.
Specialty Focus: Background or familiarization with oncology is a plus.
Education: Bachelor's degree or equivalent combination of relevant experience.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Job Tags
Temporary work, Work experience placement, Flexible hours